DEVICE: Endoform™ Natural Restorative Bioscaffold (09421906017298)

Device Identifier (DI) Information

Endoform™ Natural Restorative Bioscaffold
529304
In Commercial Distribution

AROA BIOSURGERY LIMITED
09421906017298
GS1

1
594540572 *Terms of Use
Endoform™ Natural is a 100% w/w intact extracellular matrix (ECM), manufactured from ovine (sheep) forestomach tissue. This advanced wound care device retains the innate biological structure of the native ECM, along with associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. When rehydrated with wound exudate or sterile saline, Endoform Natural transforms into a soft conforming sheet, which is incorporated into the wound over time.
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Device Characteristics

MR Safe
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45023 Collagen wound matrix dressing
A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KGN Dressing, Wound, Collagen
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092096 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Endoform Natural should be stored at room temperature in a clean and dry area.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 10 x 12.7 cm - 4 x 5"
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Device Record Status

db29e5a3-40a5-4c69-a78e-8c6c4ac632bf
April 09, 2025
2
August 20, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
09421906017403 10 09421906017298 In Commercial Distribution Carton
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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